Thin film dosage formats are known in the art. One of the often cited advantages of thin film dosage formats is the rapid dissolution of the thin film. This rapid dissolution provides for the immediate availability of an active ingredient in the thin film. Although this rapid availability characteristic of thin films can be very useful, it also entails certain disadvantages.
The absorption of an active ingredient after oral administration depends on several variables, including the release of the active ingredient from the dosage format, the dissolution or solubilization of the active ingredient under physiological conditions, and the permeability of the active ingredient across the oral mucosa and gastrointestinal tract.
New drug applications (NDAs) submitted in the United States to the Food and Drug Administration (FDA) contain bioavailability data and in vitro dissolution data, that, together with chemistry, manufacturing, and controls data, characterize the quality and performance of the drug product. This information for approved drugs can be found in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Once the specifications are established in an NDA, the dissolution specifications for batch-to-batch quality assurance are generally also published in the United States Pharmacopeia (USP) as compendial standards, which generally become the official specifications for all subsequent products with the same active ingredients.
Acceptable bioequivalence data and comparable in vitro dissolution and chemistry, manufacturing, and controls data are required for approval of abbreviated new drug applications (ANDAs) (21 CFR 314.94) in the United States. Regulations at 21 CFR part 320 address the requirements for bioavailability and bioequivalence data for approval of drug applications and supplemental applications.
Accordingly, it would be highly desirable to provide an improved edible film, and processes for making the same, that permitted modulating the dissolution, plasma peak height, bioavailability and/or bioequivalence of an active ingredient delivered in an oral thin film format such as to facilitate meeting compendial values for reference products in the United States, and their equivalent in other countries. It would also be desirable to provide time release dosage formats and methods that reduce the necessity of administering therapeutic compounds, drugs and other agents invasively (e.g., such as by injection) and that permit the delivery of medicants at a specific rate over time by oral administration. These and other advantages of the present invention are disclosed herein.